QA Engineer contract

Description

Summary of Position with General Responsibilities:

• Applies quality engineering principles and techniques to ensure that the products developed and manufactured by the division meet/exceed performance specifications and regulatory standards
• Works within the Quality Group to support manufacturing and provide decisive, scientifically based solutions to process problems and support process improvement
• Utilises quality engineering methods to ensure that the product design is transferred into manufacturing processes that are capable of reliably delivering products that are safe and effective
• Ensures that the division complies with all applicable procedures, regulations and standards during development and manufacture of its medical device products
• Applies risk management, change control and validation principles and techniques throughout product lifecycle
• Applies and improves procedures for consistent and effective implementation of quality system and regulatory requirements in the area of responsibility
• Participates in CAPA/Action Item Tracking/Audit maintenance activities

Essential Job Functions:

Participates in day to day quality activities to ensure conforming materials are available for manufacturing. Works on problem solving and investigations to determine root cause of material non conformances/customer complaints

Ensures compliance to quality system requirements as defined by companies procedures, FDA QSR, ISO 13485 and applicable international/national standards through active participation in the divisional/cross divisional product and process development system

Provides Quality Engineering representation on cross-functional product development teams

Performs timely disposition of non-conforming Supplier materials to ensure continued material compliance

Leads cross-functional teams to develop risk assessments and risk controls

Supports development of appropriate product/component specifications and supports development and validation of inspection/test methods

Supports pre-production QA activities and ensures information is adequately transferred during design transfer by interfacing with Operations, Engineering and Validation groups

Applies risk management, change control, and validation principles throughout the product lifecycle

Supports the divisional CAPA program by applying root cause analysis and problem solving techniques and by implementing corrective/preventive actions

Education and Experience:

Engineering or Science degree required

Experience in risk-based decision making and problem-solving

Experience in medical device industry or similar industrial environment